NCT00563303已完成2 期
Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria
研究概览
简要总结
Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic complications and organs injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age superior of 15 years
- •Hospitalization in reanimation for polytraumatism (lesion of two organs with a vital risk)
- •SISS score more than 15
- •Intubation for more than 48 hours.
- •Agreement of a family member
- •Patient with insurance
排除标准
- •History of corticothérapies within 6 months
- •History of adrenocortical insufficiency.
- •Treatment by immunosuppressor
- •Immunodeficiency.
研究组 & 干预措施
P
Placebo Comparator
Treatment by NaCl (placebo)
干预措施: NaCl (Drug)
H
Experimental
Hydrocortisone
干预措施: hydrocortisone (Drug)
结局指标
主要结局
Incidence of nosocomial pneumopathy: radiological, clinical and bacteriological criteria
时间窗: 28 days
次要结局
- Incidence of bacteremia, urinary infections, infections of the operatory sites, incidence of SDRA, organ dysfunction,mortality, etc.(28 days)
- Incidence of nosocomial pneumopathy(Day 8)
研究者
研究点 (12)
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